Keywords

Introduction

The days of radiation and fluoroscopy as a mean to guide catheters inside the heart in the EP lab are counted. Awareness from EP physicians and health personnel trends to reduce fluoroscopy utilization, not only to reduce impact of radiation on patients, but also to reduce the higher impact on the EP personnel exposed to radiation in an everyday basis (Chap. 2 is dedicated to this matter); in the next paragraphs we describe how to expand 3-D mapping system utilization and how to justify the increment in cost expected.

Components of Cost at the EP Lab

It would be too simple to ascribe cost only to the material used for each procedure, of course there is cost related to the consumable or expandable material, but even this cost varies widely around the world, as many countries accept the reutilization of single-use catheters for EP procedures. We will analyze all components of cost at the EP lab, and how 3-D mapping systems could actually help in cost content, using different strategies.

  • EP lab construction : The highest piece of cost at any EP lab is actually the fluoroscopy equipment; it requires the construction of a special room, with radiation blinding, and with a structure to support the heavy weight of single or biplane systems. The cost to set up a new EP lab counts for 4–5 times the marketed price of any 3-D mapping system. We can argue that we do need anyway the lab to perform EP procedures, but, what if 90% of EP procedures could be done outside the EP lab? This is the case now. Most of single centers reporting their experience on non-fluoroscopic procedures (all substrates: left sided and atrial fibrillation included) achieve in 90–100% of cases a total fluoroscopy-free procedure [1,2,3,4]. When less experienced or all comer operators report their results, there is also a 80–90% of chances that a case finishes without the need of any fluoroscopy [5, 6]. It is then tempting to perform procedures outside the EP lab, so we can eliminate the cost of an EP lab; this approach has been already tested by a pediatric center, left-sided ablations included, with same results, same complication rate, and no need of fluoroscopy in either environment (neither at the cath lab nor at the operating room used for this experience) [7]. We can affirm that ablation of most substrates, with a 3-D mapping system only use, outside the traditional EP or cath lab will be the norm in following years, thus reducing the cost of building new and expensive cath or EP labs. In the rare case the fluorsocopy is needed, to use a mobile digital X-ray equipment (widely available in all institutions) is a cost-conscious option, providing enough detail with a fraction of the cost of the standard EP lab.

  • Consumables, catheters, and patches: As many places in the world reuse catheters intended to single use (a survey published in 2001 showed that in the USA, 49% of EP labs reprocess and reuse catheter to a some extent [8]), most of 3-D mapping system providers have developed different strategies to force to adhere to a single-use policy of at least some part of their system components. EnSite NavXTM, one of the systems mostly utilized, is an open platform; any catheter can be used, so they base their business model selling the patches needed at around twice the price of any standard ablation catheter; they have evolved now to the EnSite Precision TM (latest version) that better perform with the use of proprietary sensor-enabled diagnostic and ablation catheters. CartoTM uses since the beginning proprietary sensor ablation catheters with cost escalating at least at four times the cost of a standard ablation catheters, the patches needed are marketed at very low price, encouraging users to start a case always with the patches on board in case CartoTM is needed later during the case because of a clinical reason. RhythmiaTM started with a proprietary unsurpassed diagnostic ultra density mapping basket catheter, marketed around ten times the cost of any standard ablation catheter, and there are also now available sensor-enabled proprietary catheters, matching CartoTM features. Cost of consumables is, however, a business moving target; the less units a company sell, the higher the price that consumable needs to be marketed; in other words: we can deal the price on volume: if a 3-D mapping system is used 3–5 times a day instead of only once or twice a week, prices could go down. In our lab where strict single-catheter use policy is in place, we started with one of the three providers, we calculate the cost of a standard procedure using 4–5 catheters, we agreed on how much more we could bear as an extra cost for a bundled non-fluoro kit (patches, ablation catheter and coronary sinus catheter, as we judged that for most of standard cases a two catheter approach would be enough) and we now use that kit for every patient. Once the first agreement was achieved, we approached the other two providers, and we informed them that if they wanted to do business with us, they should match the non-fluoro kit bundled price; and they did. As a beneficial side effects (for both sides) we never cancel now a difficult arrhythmia substrate (in the past as the provider representative technician needed to be scheduled, we ended some times in EP study only and scheduling the case for a later date with a 3-D mapping system), and even if this cost has not been calculated yet, it cuts hospital and consumables costs; companies can also save as their technicians are not longer always needed, and they can even train their technicians at our lab (ours have become independent and due to our high volume). Another way to save money is to rely on most company policies where always a new—and expensive—catheter is developed with time. Most of simple substrate arrhythmias need also a standard catheter, and as for complex ablation targets sensor-based, irrigated, and force-measuring catheters are now the norm, there is less need and a surplus of standard noncontact force, nonirrigated catheters still produced and less and less utilized other than for non-fluoroscopic approaches. Every country and every institution has its own policy when acquiring 3-D mapping systems (purchasing with lower consumable costs versus leasing and higher consumable cost); in all cases an agreement can be obtained with one or more providers, based on volume to deal a win-win scenario.

  • Patients and health personnel work force: There should be no cost trading to prevent a cancer at a later stage in life (either for a patient or health provider), or to prevent lumbar (four times higher in EP physicians than non-interventional cardiologists in Canada [9]) or cervical spondylosis . There is no safe radiation exposure for pregnant patients needing an invasive EP procedure (a need appearing four times in our first 300 patients), and policies in most labs prevent further work in a standard EP lab for any member of the personnel once pregnancy has been confirmed due to radiation exposure risk. A small but increasing trend in most EP labs is also the choice of this field for more and more female physicians, nurses, and technicians: in 2003 only 8% of all cardiologist were female in the USA [10], but a more recent German survey showed an increase of female cardiologist training in EP from 26% in 2010 to 38% in 2015 [11]. There are some economic models derived from a randomized Italian study (NO-PARTY trial, assigning patients to conventional fluoroscopy or minimally fluoroscopic approach—MFA—for supraventricular arrhythmias with EnSite NavXTM); the study showed a complete elimination of fluoroscopy in 72% of patients assigned to MFA; however this was enough to model a reduction of 96% of the risk of cancer incidence and mortality in the MFA group, and to consider the cost increment due to 3-D mapping system utilization, affordable for most European countries [6]. Another study on cost-effectiveness on a pediatric population stated that modeling for an effective dose reduction of 2.8 mSv per procedure, the additional cost incurred was not cost-effective for most countries, but when a children correction factor was added, the use of 3-D mapping systems is cost-effective [12]. If these models using modest exposure reductions, work for patients, imagine how much more they should work for physicians (the ones closer to the X-ray source) and health care personal, exposed in busy labs to constant radiation; there are no models yet on this matter as all interventional cardiologists we have grown with fluoroscopy as a friend; newer generations would see the benefits of working in a fluoroscopy-free EP lab. Once more, we prone that cost-effectiveness is a moving target, only incremental cost of 3-D mappings is calculated in most models; once this technique becomes widely adopted, cost of hardware will decrease; and once we use less and less fluoroscopy effective dose reductions will be even greater. In the mean time we cannot wait and we should be prepared when a pregnant patient needs our expertise, or the more frequent scenario: when a female health care provider wants to continue her professional career while pregnant.

Cost Containment When Using 3-D Mapping Systems for All Cases at the EP Lab

As we mention before, using a 3-D mapping system for everyday cases, prepares for success: there is no arrhythmia substrate that cannot be addressed, and if a complex arrhythmia appears, masked as an easy target, we have all the hardware needed to finish the case without the need to reschedule. It saves costs for the patient and the system.

An approach with lesser catheters (due to the other features available with any 3-D mapping system) makes it easier to discharge the patient the same day; two punctures only at the same groin side would eventually reduce vascular complications and helps to earlier mobilization and discharge. It saves costs for the patient and the system.

Pregnancy in a female health provider working in a fluoroscopy-free EP lab is no longer a problem. If she decides to continue working, it allows to smoothly prepare replacement personnel or to work as long as decided with no harm for the baby. It saves costs for the system, but specially welcomes female colleagues to EP labs.

I briefly mention—as there is no cost analysis yet done—the benefits for primary operators : once we have adopted this technique, there is no way to come back and to bear the weight of lead aprons; cancer and spine problems prevented would never been counted, as we would be retired at that time, only newer generations of EP will see the benefits of a fluoroscopy-free EP lab.

Catheter reutilization is another way to save money, but as previously described, most of 3-D providers have hardware or software in place to force physicians to single use, please see next section for details. If a single-use policy applies to your center, the only way to decrease costs is to deal on volume, as described before. If reuse of catheters is available, either ethylene oxide [13] or hydrogen peroxide plasma [14] sterilization is an accepted option, with a 15 h of detoxification period suggested before another use when ethylene oxide is utilized [13].

We will discuss now less orthodox methods to cut on costs when using specific 3-D mapping systems. We should disclose that these methods could not be approved or not be feasible in different jurisdictions, and for sure the specific providers do not promote these inventive utilization of their systems; however, as they cannot harm, we let the reader to decide if they are applicable at each individual institution.

  • EnSite NavXTM : The cost comes not from catheters but from patches that are labeled as single use. If in most countries reuse of a patch is not acceptable because of hygiene and contamination reasons, however, the patch can be actually used in more than one patient, provided that the session is still open for the same patient: the day starts with a case that ends just at the end of that day or when a new set of patches is used. For uninsured populations or low-income countries, it can decrease at least in three or four times the cost of a 3-D procedure without fluoroscopy (the anecdotic reuse of patches in a single day), a luxury not otherwise affordable in these settings.

  • CartoTM: Cost is attached to the ablation catheter. If reuse is allowed in your lab, the company states that internal software prevent all Navistar catheter utilization after 24 h of first use. Anecdotic reports showed the use of a catheter as the last case of a day on the lab, to send it to sterilization at night, and to still be able to reuse as the first case in the next morning, before the 24 h expiration period. In centers when a single-use policy is the norm, we decrease the costs of an EP study only (when no arrhythmia target is found) or when cryoablation is needed, in the following way: we start the day with a case where ablation is always needed (usually flutter ablation); if the next case has no arrhythmia documentation or cryoablation is the source of energy chosen, after brief decontamination, we keep the first Navistar catheter of the day and we place it on a plastic bag beneath the next patient mattress or under the table linen, still connected to the system. A decaNav catheter (marketed usually at the same price of a standard decapolar catheter) or any other sensor-enabled catheter needed is then used to create a virtual anatomy. An extra quadripolar catheter is used to complete the set up, and if the case ended up as an EP study, only two cheap diagnostic catheters have been used, without fluoroscopy and without compromising the single-use policy as the reused catheter is at the exterior of the patient. When a cryoablation catheter is needed, once the virtual anatomy has been created, it can be used and visualized as other any non-sensor-enabled catheter.

  • RhythmiaTM: We have not developed yet any trick for Orion reuse, it is supposed to have the same constraints as any sensor-based catheters, same tricks as CartoTM mentioned applies for sensor-based catheters (but there is no sensor-enabled decapolar catheter as the decaNav from CartoTM to acquire virtual anatomy).

Conclusion

The non-fluoroscopic approach for a daily life EP lab has grown as a feasible and safe alternative to fluoroscopy for any ablation procedure. With actual parameters on reduction to radiation exposure, for patients it is either cost-effective (pediatric populations) or borderline cost-effective (adult only population). There is no data on cost-related issues related to the operator and health allied professional exposure. Further developments should decrease costs. In the meantime, greater volume utilization allows to better deal when 3-D mapping systems are widely applied to all arrhythmia substrates. We have also described some methods to cost containment (applicable only if local regulation allows), to help to easy our journeys without fluoroscopy.